Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 011836
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRESAMINE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None No No
PRESAMINE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
PRESAMINE IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/16/1959 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/1984 SUPPL-72 Labeling

Label is not available on this site.

05/01/1984 SUPPL-71 Labeling

Label is not available on this site.

05/04/1983 SUPPL-69 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/20/1981 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1980 SUPPL-67 Labeling

Label is not available on this site.

04/16/1980 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

04/16/1980 SUPPL-65 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1980 SUPPL-64 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1979 SUPPL-63 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/1980 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

12/01/1978 SUPPL-61 Labeling

Label is not available on this site.

01/29/1980 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1980 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1978 SUPPL-58 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/21/1978 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1978 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1976 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1976 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1975 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1975 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1976 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1974 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English